This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Senior Manager of Biomarker statistics will be involved in the design, execution, analysis, and reporting of Biomarker endpoints in support of clinical studies across Modernas development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients
Heres What Youll Do:
Serve as the biostatistics leader and point-of-contact in multiple clinical development teams responsible for determining Clinical Biomarker study strategies and delivering results with high quality and on time
Bring innovative statistical thinking and methodologies to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs, particularly in regards to statistical methodology and experimental design in assay development
Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types
Develop statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses
Plan, manage, and track biomarker related biostatistical activities, timelines, and resources and assure operational excellence
Support interactions with regulatory agencies and effectively address the statistical questions and requests regarding Biomarker endpoints
Review and/or author SOPs and/or work Instructions related to biostatistics practices
Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
Oversee statistical contractors / consultants and manage / mentor junior team members
Heres What Youll Bring to the Table:
PhD (or equivalent degree) with 3+ years of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 6+ (Sr Manager) of relevant experience.
Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems
Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
Experience working with CROs, vendors, and relationship management preferred.
Experience in Statistical Analysis supporting assay development, qualification and validation is highly desirable
Outstanding communication skills (verbal and written).
Ability to manage multiple projects in a fast-paced environment.
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary winter shut down
Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.